The purpose of this study is to determine the safety, tolerability and pharmacokinetics of ALN-HBV in healthy adult volunteers and patients with chronic hepatitis B virus (HBV) infection. In addition, the study will assess antiviral efficacy of ALN-HBV in patients with HBV.
The study has 3 parts. Part A is a single ascending dose (SAD) study in healthy volunteers. Part B is a single ascending dose study (SAD) in patients with HBV infection. Part C is a multiple ascending dose study (MAD) in patients with HBV infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
Ascending doses of ALN-HBV by subcutaneous (sc) injection
Calculated volume to match active comparator
Clinical Trial Site
Adelaide, South Australia, Australia
Clinical Trial Site
Fitzroy, Victoria, Australia
Clinical Trial Site
Parkville, Victoria, Australia
Clinical Trial Site
Hong Kong, Hong Kong
Proportion of subjects experiencing adverse events
Time frame: Part A (SAD phase): through Day 29; Part B (SAD phase): through Day 85; Part C (MAD phase): through Day 176
Profile of Pharmacokinetics (PK) of ALN-HBV
Maximum plasma concentration (Cmax)
Time frame: Part A (SAD phase): Day 1; Part B (SAD phase): Day 1; Part C (MAD phase): Days 1 and 85
Profile of Pharmacokinetics (PK) of ALN-HBV
Elimination half-life (t1/2)
Time frame: Part A (SAD phase): Day 1; Part B (SAD phase): Day 1; Part C (MAD phase): Days 1 and 85
Profile of Pharmacokinetics (PK) of ALN-HBV
Area under the concentration-time curve (AUC)
Time frame: Part A (SAD phase): Day 1; Part B (SAD phase): Day 1; Part C (MAD phase): Days 1 and 85
Change from baseline in quantitative hepatitis B surface antigen (HBsAg) levels
Change in HBsAg levels from baseline
Time frame: Part B (SAD phase): baseline through Day 85; Part C (MAD phase): baseline through Day 176
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Clinical Trial Site
Auckland, New Zealand
Clinical Trial Site
Singapore, Singapore
Clinical Trial Site
Seoul, South Korea
Clinical Trial Site
Seoul, South Korea
Clinical Trial Site
London, United Kingdom